DeviceClearance

BIOSTREP A-DIRECT STREP A ANTIGEN TEST— 510(k) K983386

Substantially Equivalent

Princeton BioMeditech Corp.

FDA 510(k) clearance K983386 for BIOSTREP A-DIRECT STREP A ANTIGEN TEST, Substantially Equivalent on 1998-11-25. Applicant: Princeton BioMeditech Corp.. Device class: 1.

Clearance details

Applicant
Princeton BioMeditech Corp.
Product code
Code GTY
Device class
Class 1
Regulation
21 CFR 866.3740
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Monmouth Junction, NJ, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code GTY

view all

More clearances from Princeton BioMeditech Corp.

view all

Adverse events under product code GTY

product code GTY
Death
2
Total
2

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.